NCT07433855

Brief Summary

This study was conducted to evaluate the efficacy and safety of heat-treated Lactiplantibacillus plantarum LM1004 in improving immune function in adults. This was a randomized, double-blind, placebo-controlled, single-center clinical trial. Healthy adults aged 19 to 75 years who met the eligibility criteria were enrolled and randomly assigned to receive either the study product or a placebo. Participants in the study group received heat-treated Lactiplantibacillus plantarum LM1004, while participants in the control group received a placebo. The study product or placebo was taken once daily for 8 weeks. The primary outcome of the study was the change in natural killer (NK) cell activity from baseline. Secondary outcomes included changes in immune-related biomarkers, such as cytokines, white blood cell counts, total IgE levels, and fatigue-related questionnaire scores. Safety was evaluated by monitoring adverse events, vital signs, and laboratory test results throughout the study period. The results of this study were intended to determine whether daily intake of heat-treated Lactiplantibacillus plantarum LM1004 is safe and may help improve immune function in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

February 19, 2026

Last Update Submit

February 19, 2026

Conditions

Immune Function

Outcome Measures

Primary Outcomes (1)

  • Change in Natural Killer (NK) Cell Activity

    The primary outcome was the change in natural killer (NK) cell activity from baseline to the end of the intervention period.

    Baseline to Week 8

Secondary Outcomes (2)

  • Change in Immune-related Biomarkers

    Baseline to Week 8

  • Change in Fatigue-related Questionnaire Scores

    Baseline to Week 8

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in this arm received heat-treated Lactiplantibacillus plantarum LM1004 once daily for 8 weeks.

Dietary Supplement: Heat-treated Lactiplantibacillus plantarum LM1004

Placebo Group

PLACEBO COMPARATOR

Participants in this arm received a placebo once daily for 8 weeks.

Dietary Supplement: Dietary Supplement

Interventions

Heat-treated Lactiplantibacillus plantarum LM1004DIETARY_SUPPLEMENT

Heat-treated Lactiplantibacillus plantarum LM1004 was administered orally as a capsule at a dose of 500 mg once daily for 8 weeks.

Experimental Group
Dietary SupplementDIETARY_SUPPLEMENT

The placebo was administered orally as a capsule identical in appearance to the study product, once daily for 8 weeks.

Placebo Group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female adults aged 19 to 75 years
  • Able to understand the study procedures and provide written informed consent
  • Willing to comply with the study protocol

You may not qualify if:

  • History of chronic or serious medical conditions that could interfere with study participation
  • Use of medications or supplements that may affect immune function within the screening period
  • Pregnant or breastfeeding women
  • Participation in another clinical study within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong-A University Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

August 31, 2023

Primary Completion

November 13, 2023

Study Completion

November 13, 2023

Last Updated

February 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)